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Sodium monofluorophosphate toothpaste
Sodium monofluorophosphate toothpaste is a Fluoride toothpaste Small molecule drug developed by Procter and Gamble. It is currently FDA-approved for Prevention of dental caries (cavities), Fluoride supplementation for dental health. Also known as: Colgate cavity protection toothpaste, fluoride only toothpaste.
Sodium monofluorophosphate releases fluoride ions that strengthen tooth enamel and inhibit bacterial acid production to prevent dental caries.
Sodium monofluorophosphate is a small molecule used in toothpaste, studied for its potential to treat conditions such as dentinal hypersensitivity, gingivitis, calculus, and dental plaque. It is available in various formulations, including 5% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice and sodium monofluorophosphate dentifrice, which have been tested in clinical trials.
At a glance
| Generic name | Sodium monofluorophosphate toothpaste |
|---|---|
| Also known as | Colgate cavity protection toothpaste, fluoride only toothpaste |
| Sponsor | Procter and Gamble |
| Drug class | Fluoride toothpaste |
| Target | Tooth enamel hydroxyapatite; bacterial enolase |
| Modality | Small molecule |
| Therapeutic area | Dental/Oral Health |
| Phase | FDA-approved |
Mechanism of action
The fluoride ion is incorporated into the hydroxyapatite crystal structure of tooth enamel, making it more resistant to demineralization by acids produced by cariogenic bacteria. Additionally, fluoride inhibits enolase, a key glycolytic enzyme in oral bacteria, reducing their ability to metabolize sugars and produce cavity-causing acids. This dual mechanism provides both structural reinforcement of enamel and antimicrobial activity.
Approved indications
- Prevention of dental caries (cavities)
- Fluoride supplementation for dental health
Common side effects
- Dental fluorosis (mild, from ingestion during childhood)
- Mild gingival irritation
- Allergic contact dermatitis (rare)
Key clinical trials
- The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis. (PHASE3)
- A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth (PHASE3)
- Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis. (PHASE3)
- A Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health (NA)
- Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity (NA)
- Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period. (PHASE2, PHASE3)
- A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste (PHASE3)
- Comparative Efficacy of Floss and Essential Oil/CPC+Zn Mouthwashes in Reducing Dental Plaque and Gingivitis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sodium monofluorophosphate toothpaste CI brief — competitive landscape report
- Sodium monofluorophosphate toothpaste updates RSS · CI watch RSS
- Procter and Gamble portfolio CI
Frequently asked questions about Sodium monofluorophosphate toothpaste
What is Sodium monofluorophosphate toothpaste?
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Related
- Drug class: All Fluoride toothpaste drugs
- Target: All drugs targeting Tooth enamel hydroxyapatite; bacterial enolase
- Manufacturer: Procter and Gamble — full pipeline
- Therapeutic area: All drugs in Dental/Oral Health
- Indication: Drugs for Prevention of dental caries (cavities)
- Indication: Drugs for Fluoride supplementation for dental health
- Also known as: Colgate cavity protection toothpaste, fluoride only toothpaste
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing